Endovascular graft having bifurcation and apparatus and method for deploying the same

ABSTRACT

Graft having a bifurcation for repairing an aneurysm in the vicinity of an aortic bifurcation in a patient comprising a main tubular body and first and second tubular legs joined to said main body in a bifurcation. The main body and the legs are formed of a flexible surgically implantable material. The main body and each of the first and second legs having an opening therein in communication with the other openings. Expandable spring attachments are secured to the main body adjacent the opening in the main body. An additional expandable spring attachment is secured to one of said legs adjacent the opening in said one leg.

This is a division of application Ser. No. 08/066,414, filed on May 21,1993, now U.S. Pat. No. 5,489,295, which is a continuation ofapplication Ser. No. 07/684,018, filed on Apr. 11, 1991, now abandoned.The contents of each of these applications are hereby incorporated byreference.

BACKGROUND OF THE INVENTION

This invention relates to an endovascular graft having bifurcation andan apparatus and a method for deploying the same.

In Kornberg U.S. Pat. No. 4,617,932 there is disclosed a bifurcatedgraft which has two legs with one leg being longer than the other leg.There is also disclosed a device and a method for inserting the graftinto an artery. However, there is a need for an improved endovascularbifurcated graft and an apparatus and a method for deploying the same.

SUMMARY OF THE INVENTION

In general, it is an object of the present invention to provide anendovascular graft having bifurcation and an apparatus and a method fordeploying the same which makes it possible to secure the graft firmly inplace traversing the aortic bifurcation with an apparatus and methodwhich facilitates rapid deployment and placement of the same.

Another object of the invention is to provide a graft of the abovecharacter which has a body portion that can be firmly fixed in place inthis aorta and has legs which can be firmly fixed in place in the iliacarteries.

Another object of the invention is to provide an apparatus which isrelatively simple in construction and which greatly facilitatesplacement of the graft.

Another object of the invention is to provide a method of the abovecharacter which is relatively simple and error free.

Additional objects and features of the invention will appear from thefollowing description in which the preferred embodiments are set forthin detail in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of the apparatus for deploying an endovasculargraft having a bifurcation of the present invention in which the graftis disposed within the capsule ready for deployment.

FIG. 2 is a cross-sectional view taken along the line 2--2 of FIG. 1.

FIG. 3 is an enlarged cross-sectional view showing the sliding sealassembly utilized in the device shown in FIG. 1.

FIG. 4 is an enlarged perspective view of a graft having a bifurcationincorporating the present invention.

FIG. 5 is an enlarged schematic view of the capsule showing the mannerin which the graft having bifurcation is stored therein for deployment.

FIG. 6 is an elevational view partially in cross section of a minordeployment device utilized as a part of the apparatus for deploying thegraft of the present invention.

FIG. 7 is an elevational view partially in cross section of the balloondilatation catheter utilized in the minor deployment device shown inFIG. 6.

FIG. 8 is a perspective view of the hook assembly forming a part of theminor deployment device shown in FIG. 6 to be utilized with the graftshown in FIG. 4.

FIGS. 9-19 are diagrams showing the method and apparatus utilized indeploying the graft of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In general the graft having a bifurcation for repairing an aneurysm inthe aorta extending to or beyond the aortic bifurcation in a patientcomprising a main tubular body and first and second tubular legs joinedto said main body in a bifurcation. The main body and the legs areformed of a flexible surgically implantable material. The main body andthe first and second legs each have an opening therein in communicationwith the other openings. Expandable spring attachment means is securedto the main body adjacent the opening in the main body. Additionalspring attachment means is secured to the first leg adjacent the openingin that leg. The major deployment device comprises a capsule catheterand a balloon catheter. The capsule catheter comprises a flexibleelongate tubular member having proximal and distal extremities. Acapsule is mounted on the distal extremity of the flexible elongatetubular member and has an open end. A graft is disposed within thecapsule. The balloon catheter comprises a flexible elongate tubularmember having proximal and distal extremities. A balloon is secured tothe distal extremity of the flexible elongate tubular member of theballoon catheter. The flexible elongate tubular member of the ballooncatheter extends through the graft and through the capsule in which thegraft is disposed and through the flexible elongated tubular member ofthe capsule catheter. Retention means is carried by the flexibleelongate tubular member of the balloon catheter and engages the graft. Acontrol mechanism is provided and has a handle portion adapted to begrasped by a human hand and has first and second parts movable relativeto each other. Means is provided for securing the flexible elongatetubular member of the capsule catheter to the first part. The flexibleelongate tubular member of the balloon catheter extends through thefirst part and through the control mechanism. Means is carried by thecontrol mechanism for causing movement of the first part with respect tothe second part to thereby cause the capsule to be withdrawn from overthe graft and permitting the retention means to retain the graft inposition so that it is ejected from the capsule as the first part ismoved relative to the second part.

The method for deploying a graft having bifurcation with a main body andfirst and second legs for deployment across the aortic bifurcation andinto the first and second iliac arteries of a patient to repair ananeurysm therein comprising folding one of the legs of the graft so itlies substantially parallel to the main body of the graft, introducingthe graft through the femoral artery until the distal portion of thegraft is disposed proximal of the aortic aneurysm, securing the proximalextremity of the graft with the other leg of the graft being disposed inthe first iliac artery, pulling down the folded over leg into the secondiliac artery securing the distal extremity of the first leg of the graftin the first iliac artery and thereafter securing the second leg of thegraft in the second iliac artery.

The apparatus for deploying a graft 20 having a bifurcation of thepresent invention consists of a major deployment device 21 which isshown particularly in FIG. 1 and a minor deployment device 22 which isshown in FIG. 6. The major deployment device 21 incorporates a capsulecatheter 26 which is very similar to a capsule catheter disclosed inco-pending application Ser. No. 07/553,530 filed Jul. 13, 1990. Asdisclosed therein, the capsule catheter 26 is provided with a flexibleelongated tubular member 27 formed of a plastic which is loaded with aradiopaque material so that it will be visible under X-rays. An innerliner 28 of lubricous material is disposed within the tubular member 27.A flexible capsule 31 is secured to the distal extremity of the tubularmember 27. The capsule can have a length ranging from 10-40 centimetersand a diameter ranging from 6-9 millimeters.

A control mechanism 36 is secured to the proximal extremity of thetubular member 27. The control mechanism 36 is provided with a multiparthousing 37, a portion of which serves as a handle adapted to be engagedby the adult human hand. The housing 37 is formed in two parts 37a and37b of a suitable material such as plastic. The part 37a serves as acylindrical pinion housing which has a longitudinally extending bore 39formed therein opening through one end thereof. A smaller bore 41 isprovided in the pinion housing 37a and extends axially thereof and opensinto the bore 39. The part 37b is secured to the part 37a by suitablemeans such as ultrasonic bonding. The part 37b serves as a rack housing.A generally cylindrical rack member 42 is slideably mounted in the bore39. Means is provided for causing relative movement between the rackmember 42 and the pinion housing 37a and consists of a rack and pinionassembly 43. The rack and pinion assembly 43 consists of a rack 44 whichis mounted in a flat 46 provided on the rack member 42. The rack 44 isengaged by a pinion 47 mounted on a shaft 48. The shaft 48 extendsthrough the pinion housing 37a and is provided with an enlargement 48aon one end. A knob 49 is mounted on the other end of the shaft 48 and isprovided for rotating the shaft 48 by fingers of one hand of theoperator. The other hand of the operator holds the control mechanism 36.

A detent assembly 51 is provided for permitting step-by-step rotation ofthe knob 49 in one direction but preventing rotation in an oppositedirection. The detent assembly 51 consists of a plastic cylindricalhousing 52 mounted in the wall of part 37a and has a plunger 53slideably mounted therein which is yieldably urged in a directiontowards the knob 49 by a coil spring 54. The plunger 53 serves as adetent which is adapted to engage the circumferentially spaced notches56 provided in the knob 49. The notches 56 are shaped so that the knob49 can only be rotated in one direction and not in the other direction.

The distal extremity of the rack housing 37b is provided with a bore 61(see FIG. 3) which opens through the distal extremity of the same. Asmaller bore 62 is provided within the rack member 42 and extendsaxially of the bore 61 and opens into the bore 61 and also opens throughthe proximal extremity of the rack member 42. A sliding seal housing 63is provided within the bore 61 and is secured therein by suitable meanssuch as an adhesive. The housing 63 is provided with a bore 64 whichopens through the proximal extremity of the housing 63 and a smallerbore 66 extending axially of the bore 64 and opening into the bore 64and opening through the distal extremity of the housing 63. The slidingseal housing 63 is provided with an annular recess 67 on its distalextremity which is adapted to receive the proximal extremity of theflexible elongate member 27 and is bonded thereto by suitable means suchas an adhesive 28.

The major deployment device 21 also includes a balloon catheter assembly71 of the type described in co-pending application Ser. No. 07/553,530filed Jul. 13, 1990, and as disclosed therein consists of a flexibleelongate tubular member in the form of a balloon catheter shaft 72having a single lumen therein and formed of a suitable material such asirradiated polyethylene tubing. A separate balloon 74 is secured to thedistal extremity of the balloon catheter shaft 72 and is formed of asuitable material such as polyethylene. The balloon catheter shaft 72can have a suitable outside diameter such as 0.050" and extend into ametal hypo tube 76 formed of a suitable material such as stainless steelhaving a suitable outside diameter, for example 0.062". The metal tube76 extends into the inner liner 28 and extends into the bore 66 of thesliding seal housing 63 and into the bore 64 where it engages a pair ofthe spaced-apart cylindrical members 77 and 78 formed of a suitablematerial such as polycarbonate and a pair of spaced-apart siliconeO-rings 79 and 81, all of which are disposed within the bore 64 to formsliding seals. These sliding seals formed by the cylindrical members 77and 78 in conjunction with the O-rings 79 and 81 serve to prevent bodyfluids from coming into contact with operating parts of the controlmechanism 36 as for example, the rack and pinion assembly 43. Thestainless steel hypo tube 76 extends rearwardly towards the proximalextremity through the passage 62 of the rack member 42 and into the bore41 of the pinion housing 37a. A collet 82 is provided on the proximalextremity of the pinion housing 37a. Means is provided for permittingfree rotational movement of the hypo tube 76 in a fixed longitudinalposition and consists of a collet housing 83 having a threaded splitcylindrical protrusion 83a with a collet cover 84 threaded thereon. Thecollet cover 84 has a hole 85 therein through which the hypo tube 76passes. The collet housing 83 is rotatably mounted by an isolation ballbearing assembly 86 on a base 87 provided on the housing part 37a. Whenthe collet cover 84 is rotated in one direction, the collet housingprotrusion 83a is permitted to move to its normally open position topermit the collet 82 to open allowing the tube 76 to pass therethrough.When the collet cover 84 is rotated in an opposite direction it willclose the housing protrusion 83a and lock the collet 82 onto the tube76. A Luer-type fitting 88 is mounted on the proximal extremity of thehypo tube 76.

A stabilization wire 89 of a suitable material such as stainless steeland of a suitable diameter as, for example, 0.018" is disposed withinthe balloon catheter shaft 72 and extends the length thereof. Theproximal extremity 89a of the pusher wire 89 is secured in a fixedposition to the luer fitting 88 in a suitable manner such as byembedding in the wall of the fitting 88 as shown in FIG. 1. The pusherwire 89 extends through the lumen of the balloon catheter shaft 72 intothe balloon 74 where it is fastened in a fixed position in the distalextremity of the balloon 74. A flexible, pre-shaped spring-like guidewire 91 is secured to the distal extremity of the balloon 74 by use of aplug 92 which also receives the distal extremity of the pusher wire 89.

Means is provided as a part of the control mechanism 36 for supplyingliquids for injection into the capsule 31 and consists of a fitting 96(see FIG. 3) which is mounted in the rack member 42 and which isprovided with a bore 97 in communication with the bore 66. A flexibletube 99 is connected to the fitting 96 and is provided with a Luer-typefitting 101 having a stop cock 102 therein. The rack housing or cover37b is provided with a slot 103 through which the tube 99 extends andcan move longitudinally during rectilinear movement of the rack member42.

A stabilization button 106 is mounted on the balloon catheter shaft 72in a fixed position spaced a predetermined distance from the proximalextremity of the balloon 74 as for example, a distance of 5-10centimeters. A pair of spaced-apart radiopaque markers 107 in the formof platinum bands are provided on the balloon catheter shaft 72 withinthe balloon 74.

The endovascular graft 20 having a bifurcation is shown in FIG. 4. Thegraft 20 has many characteristics which are similar to the expandableintraluminal vascular graft disclosed in co-pending application Ser. No.07/553,530 filed Jul. 13, 1990. However, the graft 20 differssignificantly from the graft disclosed therein in that it is providedwith a bifurcation as hereinafter described. The graft 20 is anexpandable intraluminal vascular graft which is provided with a maindeformable cylindrical body 112 having an open end 113. The body 112 isprovided with a bifurcation or crotch 114 at the other end which opensinto first and second legs 116 and 117, having open ends 118 and 119generally opposite the open end 113. Continuous walls form the body 112and the legs 116 and 117 and are woven of surgically implantablematerial such as Dacron-type fiber. One material found to beparticularly satisfactory is a USCI DeBakey soft woven Dacron vascularprosthesis. The main body 112 can have a length ranging from 5 to 30centimeters with each of the legs having a length ranging from 2 to 15centimeters. The body 112 can have a maximum expandable diameter rangingfrom 12 to 30 millimeters whereas the legs 116 and 117 can have maximumdiameters ranging from 6 to 12 millimeters.

Radiopaque markers 121 are provided on the main body 112 and also on thelegs 116 and 117 and can be formed of a suitable material such aslengths of platinum wire secured to the fabric of the graft by suitablemeans such as Dacron sutures.

Expandable spring attachment means 126 is secured to the expandable mainbody adjacent the opening 113. Also expandable spring attachment means127 is secured to the first leg 116 adjacent the opening 118. Theseexpandable spring attachment means 126 and 127 serve as anchoring meansfor securing the graft 20 to vessel wall in which the graft 20 isdisposed. The expandable spring attachment means 126 is constructed in amanner similar to that described in co-pending application Ser. No.07/553,350 filed Jul. 13, 1990, and serves to yieldably urge the opening113 in the main body 112 from an initial compressed or collapsedposition to a subsequent expanded position. Similarly, the expandablespring attachment means 127 serves to yieldably urge the open end 118from an initial compressed or collapsed position to a subsequentexpanded position. As explained in said co-pending application Ser. No.07/553,350 filed Jul. 13, 1990, the expandable spring attachment means126 and 127 are formed of a plurality of vees 131 with the apices 132being formed with helical coil springs 133 to yieldably urge the legs134 and 136 of each of the vees 131 outwardly in directions in theplanes in which the vees lie. As disclosed in the co-pending applicationSer. No. 07/553,350 filed Jul. 13, 1990, the apices 132 lie in threelongitudinally spaced-apart parallel planes extending transversely ofthe axis of the expandable spring attachment means in which the firstplane is disposed internally of the open end and the second plane liesin a position which is external of but in close proximity to the openend and the third plane is spaced a substantial distance beyond the openend.

Hook-like elements 141 are provided at the apices 132 which are disposedbeyond the open end 113 for the attachment means 126 and the open end118 for the attachment means 127. The hook-like elements 141 are bondedto the legs 136 of the vees 131 by suitable means such as welding. Thehook-like elements 141 have hooks 142 which are of a length which issufficient to penetrate into the vessel wall and slightly beyond thevessel wall in which the graft is to be placed. The expandable springattachment means 126 and 127 are secured to the graft by Dacronpolyester suture material 144 as shown particularly in FIG. 4.

A pull line 146 is secured to the leg 117 in a region which is closelyapproximate the end of the leg 117 at the opening 119. The pull line canbe formed of a suitable material such as Nylon having a diameter from0.005"-0.010". The pull line 146 is continuous and extends through smallholes 147 provided in the material forming the graft 20. The pull line146 which is doubled over onto itself and has a doubled-over length ofapproximately 40-60 centimeters with the ends of the pull line 146 beingtied together in a knot 148. A lead tube 151 with a lumen 152 ispositioned over the pull line 146 so it is adjacent the leg 117. Thelead tube 151 is necked down at 153 by suitable means such as by heat ina region distal of the knot 148 (see FIG. 4) so that the lead tube 151is retained on the pull line 146. A cutout 154 is provided in the leadtube 151 proximal of the knot 148.

The balloon catheter assembly 71 is disposed within the capsule 31 in amanner also shown in FIG. 5 in which the balloon tube or shaft 72extends coaxially of the main body of the graft 112 coaxially of thefirst leg 116. The stabilization button 106 is preferably disposedwithin the graft in a position which is just proximal of the bifurcationor crotch 114. By positioning the pusher button 106 where shown in FIG.5, it is near to the major portion of the material forming the graft 20which is folded up within the capsule 31. This is desirable because themass of material provided in that region of the capsule facilitatespushing the graft 20 out of the capsule as hereinafter described.

The minor deployment device 22 as particularly shown in FIG. 6 consistsof a capsule catheter 161, a balloon catheter 162 and a separateexpandable spring attachment means 163. The separate balloon catheter162 is shown in greater detail in FIG. 7 and the separate springattachment means 163 is shown in FIG. 8. The capsule catheter 161consists of a flexible tubular member 166 formed of a suitable materialsuch as polyethylene having an inside diameter ranging from 0.050 to0.080" and an outside diameter ranging from 0.075 to 0.100". The tubularmember 166 can have a suitable length as for example, 15-25 centimeters.The tubular member 166 has a lumen 167 extending the length thereof andhas proximal and distal extremities 168 and 169. A conventional TuohyBorst adapter 171 is mounted on the proximal extremity 168. A smallcapsule 172 formed of suitable material such as stainless steel ismounted on the distal extremity 169 of the tubular member 166. It can beof a suitable size, as for example a length of 10 to 30 millimeters andan inside diameter of 4 to 6 millimeters with a wall thickness rangingfrom 0.006 to 0.015". The capsule 172 is provided with an open end 173through which the separate expandable spring attachment means 163 isadapted to be inserted.

The balloon catheter 162 as shown in FIG. 7 consists of a flexibleelongated tubular member 176 formed of a suitable material such aspolyethylene and which serves as the balloon shaft and is provided withan outside diameter ranging from 0.040 to 0.060" and an inside diameterranging from 0.015 to 0.030". An expandable balloon 177 is formedintegral with the flexible elongate tubular member 176 near the distalextremity thereof. The balloon 177 is formed of the same polyethylenematerial as the tubular member 176 and can have a diameter ranging from6 to 12 millimeters and a length ranging from 1 to 2 centimeters. A wyeadapter 179 is mounted on the proximal extremity 181 of the flexibleelongated tubular member 176. A Tuohy Borst adapter 182 is mounted onthe main arm 183 of the wye adapter 179. A stop cock 184 is mounted onthe side arm 186 of the wye adapter 179.

An additional elongate flexible tubular member 188 of a suitablematerial such as polyethylene is provided and extends from the TuohyBorst adapter 182 through the lumen 189 provided in the tubular member176 and through the balloon 177 where the distal extremity of theelongate flexible tubular of the member 188 is bonded to the distalextremity of the tubular member 176 to provide an airtight seal for theballoon 177. The tubular member 188 is provided with a lumen 191extending the length thereof as adapted to receive a guide wire 196 of asuitable size as for example, one having a diameter of 0.018" so thatthe guide wire 196 can extend through the tubular member 176 and throughthe balloon 177 and extend beyond the distal extremity of the tubularmember 176. The guide wire 196 is of a conventional type and is utilizedfor guiding the balloon catheter as hereinafter described. A pair ofspaced-apart radiopaque markers of a suitable material such as goldbands 198 are provided on the tubular member 188 within the balloon 177.

The coaxial annular space between the exterior of the tubular member 188and the interior of the tubular member 176 serves as an annular ballooninflation passage and is in communication with the side arm 186 so thatthe inflation and deflation of the balloon can be controlled by the stopcock 184.

The expandable spring attachment means 163 shown in FIG. 8 has aconstruction very similar to the expandable spring attachment means 126and 127 hereinbefore described. The expandable spring attachment means163 is provided with a plurality of vees 201 having apices 202 formed bycoil springs 203 which have legs 204 and 206 expandable and contractiblewithin the plane of the vee. The vees 201 are configured in such amanner so that the apices 202 lie in only two spaced-apart parallelplanes perpendicular to the longitudinal axis of the expandable springattachment means, rather than the three planes disclosed for expandablespring attachment means 126 and 127. Hook-like elements 207 are bondedto the legs or struts 204 or 206. The hook-like elements 207 areprovided with hooks 208 which face outwardly of the expandable springattachment means and in a direction towards the other end of the springattachment means. Additional hook-like elements 209 are provided on theother end of the spring attachment means 163 by bonding the same bysuitable means such as welding to the struts 204 and are provided withhooks 211 which face outwardly and extend in an opposite direction tothe hooks 208, toward the other end of the spring attachment means. Inthis way it can be seen that the hooks 208 and 211 face in oppositedirections, hooks 208 being angled slightly distally and hooks 211 beingangled slightly proximally, and serve to prevent distal and proximalmigration of the graft leg 117 to which the expandable attachment means163 is attached as hereinafter described.

The expandable spring attachment means 163 is adapted to be compressedand mounted within the capsule 172 as shown particularly in FIG. 6.Means is provided for pushing the expandable spring attachment means 163out of the open end 173 of the capsule 172 and consists of astabilization button 216 which is formed on the balloon shaft orflexible elongate tubular member 176. The pusher member 216 can beformed in a suitable manner such as by forming a ring of longitudinallycompressed polyethylene on the shaft 176.

Operation and use of the apparatus hereinbefore described for performingthe method of the present invention for deploying an endovascular grafthaving bifurcation may now be briefly described as follows.

In conjunction with the diagrams which are set forth in FIGS. 9-19, letit be assumed that it is desired to repair an aneurysm in the abdominalaorta 222 close to or involving the aortic bifurcation 221 and possiblyinvolving the left and right iliac arteries 223 and 224 in a humanpatient. In this example, the left iliac artery 223 is referred to asthe first iliac artery, and the right iliac artery 224 is referred to asthe second iliac artery. Graft legs 116 and 117 are identifiedsimilarly. Initially the patient is prepared with either general,regional, or local anesthesia. A cut-down is performed in the leftfemoral artery as indicated by the opening 226 in the first leg 223.Similarly, a cut-down or percutaneous access is performed in the rightfemoral artery as indicated by the opening 227 in the second leg 224. Aguide wire 231 of a conventional type, as for example a guide wirehaving a diameter of 0.038", is introduced through the opening 226 inthe left femoral artery 223 and then is passed over the aorticbifurcation 221 and down through the right artery 224 and out throughthe opening 227 in the right femoral artery. This procedure isaccomplished in a conventional manner under fluoroscopy as shown in FIG.9.

Thereafter as shown in FIG. 10 the lead tube 151 which is extending outof the distal extremity of the capsule 31 is threaded over the guidewire 231 extending out of the hole 226 in the first artery 223 andthence into the left cut-down or hole 226 and over the guide wire 231 inthe left artery, over the guide wire 231 in the aortic bifurcation 221and then down the second artery 224 through the right cut-down 227 sothat the distal extremity of the lead tube 151 extends for a substantialdistance out of the cut-down 227. During the time that the lead tube 151is being advanced, the distal extremity of the guide wire 231 is causedto pass through the cut-out 154 so that the distal extremity of theguide wire 231 is accessible and can be held steady while the lead tube151 is advanced over it.

Thereafter, the guide wire 231 can be pulled out by grasping theproximal extremity of the guide wire 231 adjacent the cut-out 154 in thelead tube 151 and pulling out the guide wire 231 while holding thedistal extremity of the lead tube 151 so as to prevent the lead tube 151from being pulled back into the cut-down 227. The distal extremity ofthe lead tube 151 is then clamped with a hemostat 236 as shown in FIG.11 to be sure that the lead tube 151 is not pulled back into thecut-down 227 during future steps in the method of the present invention.The major deployment device 21 is then introduced into the left cut-down226 by first passing the balloon guide wire 91 and then the balloon 74through the left cut-down 226 followed by the capsule 31, which isadvanced to the position shown in FIG. 11 by pushing on the tubularmember 27. During the advancement, the operator may need to place gentletraction on the lead tube 151 to facilitate advancement of the capsule31 toward the aortic bifurcation 221. When the capsule 31 reaches theaortic bifurcation 221, it is necessary for the operator holding thelead tube 151 to permit more of the lead tube 151 to enter the cut-down227 to permit further advancement of the capsule 31 up the aorta so thatthe proximal spring attachment means 126 of the graft 20 within thecapsule 31 can be positioned in a region which is 1-2 centimetersproximal of the proximal extremity of the aneurysm to be corrected bythe graft 20 being deployed. As shown in FIG. 12 the distal extremity ofthe capsule 31 is deployed well beyond the aortic bifurcation 221. Assoon as the physician has determined that the capsule 31 is in theproper position, the physician uses one hand to hold the controlmechanism 36 while at the same time using the fingers of the other handto rotate the knob 49 and the pinion 47 to retract the rack member 42.This causes retraction of the tubular member 27 and the capsule 31mounted thereon while the hypo tube 76 is retained in a stationaryposition by the collet 82 that is retained by the collet housing 83. Asthe capsule 31 is withdrawn, the stabilization button 106 carried by thetubular member 72 in engagement with the graft 20 as shown particularlyin FIG. 5 causes the graft 20 to be gradually ejected from the capsule31 as the capsule 31 is withdrawn. Upon continued retraction of thecapsule 31, the proximal expandable spring attachment means 126 willclear the capsule 31 and will spring outwardly to cause the hooks 142carried thereby to come into engagement with the aortic vessel wallproximal to the aneurysm to be repaired as shown in FIG. 12.

The physician, using one hand to hold the control mechanism 36, uses hisother hand to release the collet 82 in order to unlock the tube 76 byrotating the collet cover 84 relative to the control mechanism 36. Thephysician repositions the hand not holding the control mechanism 36 soas to grasp the portion of the metal hypo tube 76 extending proximallyof the control mechanism 36. The hypo tube 76 is then pulled rearwardlyor proximally. The balloon 74 is thereby drawn into the proximalextremity of the main body portion 112 of the graft 20 as shown in FIG.13 so that the intermediate portion of the balloon 74 is in generalregistration with the expandable spring attachment means 126. Theballoon 74 is then inflated by supplying gas to the balloon inflationlumen by attachment of a syringe or other suitable inflation means tothe Luer fitting 88. Upon inflation of the balloon 74 the hooks 142carried by the proximal expandable spring attachment means 126 arefirmly seated circumferentially in the normal aortic wall proximal tothe aortic aneurysm. With the balloon 74 still inflated and firmlyholding the proximal attachment means 126 against the aortic wall, thecapsule 31 is then further retracted by holding tube 76 in fixedposition relative to the patient with one hand and retracting the handle36 with the other hand in order to expose the entire length of thesecond leg 117 as shown in FIG. 13. The capsule 31 is still furtherretracted to clear most of the first leg 116 as shown in FIG. 14. Asthis is being accomplished, the second leg 117 of the graft 20 is pulleddown into the artery 224 by pulling on the lead tube 151 so that theentire length of the leg 117 of the graft 20 is disposed in the arterialvessel 224 and extends substantially below the bifurcation 221 and belowthe aneurysm which is to be repaired. Further retraction of the capsule31 is accomplished by holding tube 76 fixed with one hand and retractingthe handle 36 with the other hand until the distal expandable springattachment means 127 carried by the first leg 116 clears the capsule 31and springs into engagement with the wall of the arterial vessel 223. Itshould be appreciated that during the foregoing procedures, the balloon74 remains inflated in the attachment means 126 to prevent anyaccidental dislodgement of the attachment means 126 during the removalof the capsule 31 and during the placement of the second leg 117 of thegraft 20 into the artery 224 by pulling on the lead line 151.

The balloon 74 is then deflated so that it is in a collapsed positionand the balloon is withdrawn from the attachment means 126 into thefirst leg 117 until its intermediate portion is in registration with theattachment means 127. The balloon 74 is then reinflated to expand thehooks 142 of the attachment means 127 into firm engagement with thearterial wall of the vessel 223 as shown in FIG. 15.

After this has been accomplished, the balloon 74 is again deflated andis advanced up through the main body of the graft 112 and again into theattachment means 126. The balloon 74 is then reinflated as shown in FIG.16 and serves to hold the graft 20 in place while the procedures forsecuring the distal extremity of the second leg 117 are accomplished. Itis likely in many instances that this step of again securing theproximal extremity of the graft by inflating the balloon in theattachment means 126 may be unnecessary. However to ensure that thegraft 20 will not move after it has been deployed, as additionalinsurance, the balloon 74 can be positioned in the attachment means 126and reinflated.

The minor deployment device 22 is next utilized. The guide wire 196forming a part thereof is introduced through the cutdown 227 into thesecond artery 224 so that it extends into the second leg 117 of thegraft 20 and beyond the bifurcation. The balloon catheter 162 isthreaded onto or advanced over the guide wire 196. The balloon catheter162 is disposed within the capsule catheter 161. The minor deploymentdevice 22, with its balloon catheter 162 and capsule catheter 161, isadvanced into the cutdown 227 while applying gentle traction to the leadtube 151 to keep the second leg 117 of the graft 20 taut. The balloon177 and the capsule 172 are thus introduced into the second leg 117. Thecapsule 172 is positioned so that when the expandable spring attachmentmeans 163 contained therein is deployed therefrom, the spring attachmentmeans 163 will be at the distal extremity of the second leg 117 of thegraft 20 as shown in FIG. 16. The expandable spring attachment means 163is then forced out of the capsule 172 by the physician using one hand tograsp the wye adapter 179 and hold it in a fixed position relative tothe patient and using the other hand to grasp the Tuohy Borst adapter171 and gradually withdraw the same to retract the capsule 172 from overthe expandable spring attachment means 163 which is held in the desiredposition by the stabilization button 216 carried by the tubular member176. As soon as the expandable spring attachment means 163 clears thecapsule 172 it will spring out with one row of hooks 208 moving intoengagement with the distal extremity of the second leg 117 and with theother row of hooks 211 moving into engagement with the wall of thearterial vessel 224. Alternatively the capsule 172 is positioned so thatwhen the expandable spring attachment means 163 contained therein isdisplaced therefrom, the expandable spring attachment means 163 isdisposed within the second leg 117 so that both rows of hooks 208 and211 move into engagement with the distal extremity of the leg 117 andengage the wall of the vessel 224.

In order to firmly implant the hooks 208 and 211 of the expandablespring attachment means 163, the balloon 177 in its deflated conditionis brought down into the attachment means 163 so that its intermediateportion is disposed within the attachment means 163. This isaccomplished by pulling on the wye adapter 179 which applies a pullingforce to the tubular member 176 to pull the balloon 177 towards thedistal extremity of the leg 117 of the graft 20 while at the same timewithdrawing, if so desired, the capsule catheter 161 by pulling on theadapter 171 which applies a pulling force to the tubular member 166. Assoon as the balloon 177 is in the proper position, the balloon 177 isinflated by suitable inflation means as, for example, a syringe attachedto the stop cock fitting 184 and inflating the balloon 177 to thedesired pressure to force the hooks 208 and 211 firmly into the distalextremity of the leg 117 of the graft 20 and the arterial vessel 224.

After the inflation of the balloon 177 has been accomplished, theballoon 177 can be deflated by removing the syringe and opening the stopcock 184. The balloon catheter 162 and the capsule catheter 161 then canbe removed through the cutdown 227 so that all that remains is the leadtube 151 extending through the cutdown 227. The lead tube 151 is cutdistal to the knot 148 in the vicinity of the necked down section 153and the lead tube 151 is pulled off of the pull line 146. One end of theNylon pull line 146 is then grasped to pull out the Nylon pull line 146by having the free end travel up into the cutdown 227 and pass throughthe distal extremity of the leg 117 of the graft 20. It is then removedin its entirety through the cutdown 227. The right cutdown 227 is thenrepaired. Following that, the balloon 74 is deflated. The hypo tube 76is retracted relative to the control mechanism 36 to move the ballooninto engagement with the capsule 31. The collet 82 is then locked ontothe hypo tube 76 by turning the knob 84 relative to the controlmechanism 36. The control mechanism 36 is then withdrawn to remove thecapsule catheter 27, the balloon catheter shaft 72, and the balloon 74through the cutdown 226. The left cutdown 226 is then repaired. Thiscompletes the steps for deployment of the graft 20 across an aorticbifurcation to repair an aneurysm. The patient can then be brought outof general anesthesia if employed.

It should be appreciated that the graft having bifurcation can have legsof various lengths depending upon the type of aneurysm which is to berepaired. For example, one leg can be longer than the other. The legscan both be short in cases in which the aneurysm has a short distalaortic neck and does not include the iliac arteries. They would belonger in aneurysms which involve the iliac arteries as well. It isgenerally desirable that the graft extend at least one centimeter beyondthe most distal portion of the most distal aneurysm in the vessels.

From the foregoing it can be seen that there has been provided a grafthaving a bifurcation in which the main body of the graft as well as thelegs are firmly attached in the arterial vessels so that theyaccidentally cannot become dislodged from the location in which they arefixed in the arterial walls. The method which is utilized for deployingthe graft with legs is relatively simple and can be accomplished withina relatively short period of time. The major and minor deploymentdevices which are utilized in the procedure are constructed in such amanner that they are easy to utilize with a minimum of training. The useof a folded-over second leg of the graft in the capsule makes itunnecessary to move the main body of the graft as high in the aorta aswould be otherwise necessary in order to permit the second leg of thegraft to clear the aortic bifurcation to thereby permit the second legto be placed in the second iliac artery. Thus, the risk incurred bymoving the graft and its capsule and any associated debris past therenal arteries located well above the aortic bifurcation is greatlyreduced thereby reducing the chance of occluding the renal arteries andcausing embolization to the renal arteries.

We claim:
 1. A device for deploying a graft having a bifurcation, thedevice comprising:a capsule catheter formed from a flexible elongatetubular member having proximal and distal extremities; a capsule mountedproximate the distal extremity of the tubular member of said capsulecatheter, said capsule having an open end; a graft having a bifurcationdisposed within said capsule; a balloon catheter formed from a flexibleelongate tubular member having proximal and distal extremities andextending through said graft, through said capsule and through thetubular member of said capsule catheter; a balloon secured proximate thedistal extremity of the tubular member of said balloon catheter;retention means carried by the tubular member of said balloon catheterfor engaging said graft; and a control mechanism including a handlehaving first and second parts movable relative to each other, whereinthe proximal extremity of the tubular member of said capsule catheter issecured to the first part, and wherein the tubular member of saidballoon catheter extends through the first part, said control mechanismfurther including means for causing relative movement of the first partwith respect to the second part so as to withdraw said capsule from saidgraft, wherein said retention means retains said graft in a fixedposition relative to said balloon catheter.
 2. A device as in claim 1wherein said graft has expandable anchor means capable of movingoutwardly as soon as the expandable anchor means clears the capsule. 3.A device as in claim 1 wherein said means for causing relative movementbetween the first and second parts includes a rack and pinion.
 4. Adevice as in claim 1 wherein said control mechanism includes means forpreventing longitudinal movement of the flexible elongate tubular memberof the balloon catheter relative to the control mechanism.
 5. A deviceas in claim 4 wherein said control mechanism includes means foroperating on said means for preventing longitudinal movement of theflexible elongate tubular member of the balloon catheter to permitlongitudinal movement of the flexible elongate tubular member of theballoon catheter relative to the control mechanism.
 6. A device as inclaim 1 wherein said graft is in the form of a main body and first andsecond legs adjoining the main body and extending away from the mainbody to provide a bifurcation, one of said legs being folded over andlying generally parallel to the main body when the graft is disposedwithin the capsule.
 7. A device as in claim 6 together with a lead tubeconnected to the folded-over leg and extending out of said capsule.
 8. Adevice as in claim 7 together with a single pull line secured to saidleg and extending through said leg and having its free ends knottedtogether, said lead tube extending over the pull line into the vicinityof said capsule and means formed in the tube engaging the knot toprevent the lead tube from being pulled off of the pull line.
 9. Adevice as in claim 8 wherein said lead tube is provided with a cutoutproximal of the knot.
 10. A device for deploying a graft, the devicecomprising:a capsule catheter formed from a flexible elongate tubularmember having proximal and distal ends; a capsule mounted proximate thedistal end of said capsule catheter, said capsule having a closedproximal end and an open distal end; a bifurcated graft disposed withinsaid capsule, said bifurcated graft configured with a main tubular body,a first leg and a second leg, said bifurcated graft including a firstattachment system secured to the main tubular body; a balloon catheterformed from a flexible elongate tubular member having proximal anddistal ends, said balloon catheter extending through said capsulecatheter and through said capsule; a balloon formed on the tubularmember of said balloon catheter; and a control mechanism including ahandle and an assembly disposed within the handle, wherein the proximalextremity of said capsule catheter is secured to the assembly such thatthe tubular member of said balloon catheter extends through the assemblyand through the handle, said control mechanism further including meansfor retaining said balloon catheter stationary relative to the handle,and wherein the assembly is configured to cause relative movement of thecapsule catheter with respect to the handle so as to move said capsulerelative to said balloon catheter.
 11. The device of claim 10, whereinsaid bifurcated graft further includes a second attachment systemsecured to the first leg proximate the opening of the first leg, whereinsaid attachment system is disposed within said capsule.
 12. The deviceof claim 11, further including a pull line secured to the second leg ofsaid bifurcated graft proximate the opening of the second leg andpartially disposed within said capsule.
 13. The device of claim 10,wherein the assembly of said control mechanism includes a rack andpinion.